Amgen
AMGN
has announced positive preliminary data from a phase III study on ABP 654, its biosimilar candidate, to
J&J
’s
JNJ
blockbuster drug Stelara (ustekinumab) in plaque psoriasis indication.
The phase III study compared the safety and efficacy of ABP 654, Amgen’s investigational Stelara biosimilar with the original Stelara drug in adult patients with moderate to severe plaque psoriasis.
The study achieved its primary efficacy endpoint of percentage improvementof psoriasis area severity index (PASI) at week 12 from baseline. Data from the study demonstrated no clinically meaningful differences between the biosimilar candidate and J&J’s branded drug. Although a mean difference of percentage improvement of 0.14 was observed between the biosimilar candidate and the original product, the same was within the prespecified limit.
In the year so far, Amgen’s stock price has risen 12% against the
industry
’s 13.3% fall.
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Stelara is a human IL-12 and IL-23 antagonist approved by the FDA for the treatment of moderate to severe plaque psoriasis in individuals aged six years and older. J&J has also secured label expansion for the drug in Crohn’s disease, psoriatic arthritis and ulcerative colitis indications.
However, the latest U.S. and European patents for Stelara pertaining to the composition of matter will expire in 2023 and 2024, respectively. Evidently, Stelara is JNJ’s largest product, which accounted for 9.7% of its total 2021 revenues. For the full year, J&J recorded revenues of $9.1 billion from Stelara sales. A potential approval for ABP 654 will help Amgen strengthen its biosimilar business.
Amgen’s biosimilar business is a key part of its growth strategy. The company’s biosimilars revenues are annualizing at above $2 billion in sales while it is anticipated to more than double from 2021 to 2030. AMGN is presently marketing four biosimilars in the United States.
Apart from ABP 654, Amgen is evaluating two other biosimilars in late-stage development. These are ABP 938, the company’s biosimilar candidate to
Regeneron
REGN
/
Bayer
’s
BAYRY
Eylea and ABP 959, a biosimilar candidate to AstraZeneca’s Soliris. Top-line data from the studies evaluating these two candidates are also expected later this year.
Eylea is an anti-VEGF treatment that has been developed by Regeneron in collaboration with Bayer‘s HealthCare unit. Regeneron/Bayer’s Eylea has been approved by the FDA for multiple retinal indications, including diabetic macular edema, wet age-related macular degeneration and macular edema following retinal vein occlusion. While Regeneron records net product sales of Eylea in the United States, Bayer records its net product sales outside the country.
Zacks Rank
Amgen currently carries a Zacks Rank #3 (Hold). You can see
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